Status:
NOT_YET_RECRUITING
Safety and Immunogenicity of Cat-allergen Intralymphatic Immunotherapy in Patients With Cat Allergy With and Without Asthma
Lead Sponsor:
University of Zurich
Conditions:
Allergic Rhinitis
Allergic Asthma
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
PHASE2
Brief Summary
The goal of this clinical trial is to evaluate the safety and tolerability of intralymphatic immunotherapy (ILIT) with ALUTARD SQ Felis domesticus in patients with cat allergy-induced allergic rhiniti...
Detailed Description
Patients with allergic rhinitis and asthma due to sensitisation to cat allergens are seldom offered allergen immunotherapy (AIT) due to risk of systemic allergic adverse events such as asthma exacerba...
Eligibility Criteria
Inclusion
- Informed consent as documented by signature.
- Cat-dander-induced ARC as confirmed by patient history and type-1-sensitization to cat dander in skin and/or serum.
Exclusion
- Hypersensitivity to phenol.
- Planned depot steroid injection for treatment of ARC
- Patients with uncontrolled asthma or FEV1 \< 70% of the predicted value in adults (after adequate pharmacological therapy).
- Patients with a severe asthma exacerbation in the past 3 months.
- Irreversible secondary changes in the affected organ (e.g., emphysema, bronchiectasis).
- Chronic obstructive or restrictive lung disease.
- Patients with active systemic autoimmune diseases and patients with immune deficiencies or immune weaknesses.
- Severe chronic inflammatory diseases.
- Concomitant infection with fever or other signs/symptoms of an acute or chronic infection at treatment visit.
- Chronic obstructive or restrictive lung disease
- Patients with malignant tumours that currently have clinical significance.
- Disease or conditions rendering the treatment of anaphylactic reactions difficult (symptomatic coronary heart diseases, severe arterial hypertension, and treatment with beta-blockers).
- Known cardiovascular disease, i.e., not even NYHA class I.
- Use of ACE-blockers.
- Recent or on-going hepatic or renal disease.
- Severe chronic renal insufficiency (due to aluminium burden).
- Alcohol or drug abuse
- Women who are pregnant and breast feeding
- Women of childbearing age who wish to become pregnant or do not use contraception.
- Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant.
- Participation in another study with investigational drug within the 30 days preceding and during the present study.
Key Trial Info
Start Date :
August 26 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 31 2028
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT06960382
Start Date
August 26 2025
End Date
March 31 2028
Last Update
July 20 2025
Active Locations (1)
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1
University Hospital Zurich
Zurich, Switzerland, 8091